QA Systems Specialist - eQMS & CSV Projects

MedPharm-posted 3 months ago
Durham, NC
51-100 employees
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QA Systems Specialist – eQMS & CSV Projects will be leading and supporting the implementation, migration, validation, and ongoing management of key electronic Quality Management Systems (eQMS) and pharmaceutical computerized systems at MedPharm. This includes acting as a Subject Matter Expert on MasterControl, and other digital tools used to manage pharmaceutical quality data, ensuring compliance with GMPs, Annex 11, and applicable regulatory standards.

  • Effectively manage key Pharmaceutical Computerized System projects: delivering according to plan.
  • Have a good working knowledge of electronic Quality Management System and its practical implementation at MedPharm.
  • Lead and support the implementation of new tools in the electronic Quality Management System (e.g., MasterControl), ensuring smooth transition and compliance throughout all phases.
  • Act as the Subject Matter Expert (SME) for eQMS platforms including MasterControl – provide training, troubleshooting, and ongoing support.
  • Own and manage system lifecycle documentation – URS, risk assessments, IQ/OQ/PQ, data migration plans, and SOPs.
  • Promote a culture of acceptance to change in support of an ongoing programs of companywide improvement.
  • Provide regular updates to Senior Management and key stakeholders including metrics reports highlighting risks and issues with existing systems, and new system implementation and development.
  • Support employees working on Computerized System projects such as computerized lab equipment.
  • Ensure adherence to GMPs, Annex 11 & 15, GLP and latest industry guidance during project activities.
  • Ensure that all key process personnel are appropriately trained prior to implementation of a new Computerized System procedure.
  • Drive post-implementation reviews and continuous improvement of computerized systems.
  • Support the eQMS as a subject matter expert on Computer systems used to store and process pharmaceutical data.
  • Maintain compliance and audit readiness for all electronic systems.
  • Act as the Records Archivist and manage archiving process.
  • Mentor users and super-users; deliver training programs on validated systems.
  • Perform other duties as requested by management.
  • Bachelor’s in Life Sciences, Engineering, Computer Science, or related discipline desirable but not essential.
  • Training in Computer System Validation in a Pharmaceutical GMP environment and familiarity with GAMP 5 with 3-5 years experience working in the pharmaceutical industry preferred.
  • Familiar with Quality Management Systems is desirable (Deviations, Change Controls, CAPAs, etc.).
  • Proven experience working with MasterControl, or similar eQMS platforms – configuration, administration, and user training.
  • Strong working knowledge with CSV and GxP system implementations in a regulated pharmaceutical or life sciences environment.
  • Hands-on experience with CSV activities relating to Empower CDS, including validation of new Empower installations and version upgrades, data migration and system archiving, management of audit trails, user access, and data integrity in Empower.
  • Demonstrable success in leading system migrations or large-scale QMS digitalization projects.
  • Experience in writing and maintaining validation documentation in line with GAMP 5.
  • Good working knowledge of Computer System Validation.
  • Familiar with electronic quality management systems (eQMS).
  • Familiar with environmental monitoring systems.
  • Experience working within a Quality function on computer systems integration projects.
  • 10% travel requirement (possible 1 to 2 trips per year)
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